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NCT Number: NCT06940882

Development of a Novel Screening Tool for Anosognosia After Stroke.

Anosognosia, a neurological inability to acknowledge or comprehend one's own (dis)abilities, is a multi-faceted phenomenon which has consistently gained traction in research fields spanning psychology, neurology, and cognition since its conceptual introduction in 1914. Though anosognosia is not limited to following only neurological disease or injury, the majority of research has focused on the prevalence and mechanisms of anosognosia after stroke. Despite this, there is no clear consensus among the literature, and thus in clinical practice, as to how anosognosia after stroke should be assessed. This is startling given the plethora of studies which highlight anosognosia as a barrier to rehabilitation, a risk to safe discharge, and a predictor of poorer psychological and functional outcomes for both patients and their carers. Currently, there exists a vast number of assessment methods for anosognosia after stroke, which vary from performance- and observation-based tasks to self-report and discrepancy-based interviews; clinicians working in stroke make arbitrary choices as to which of these methods to use on a case-by-case basis, risking missed cases and subsequently noncomprehensive care. This research aims to develop a new screening tool for anosognosia that can be routinely implemented with post-stroke patients in hospital settings, to inform care, rehabilitation, and discharge. The study will explore the acceptability and feasibility of the new screening tool among multi-disciplinary staff working on a stroke rehabilitation unit, and provide grounds for future studies to assess the screen's psychometric properties and ability to inform novel interventions for anosognosia. Findings will have great implications for stroke survivors, their carers, and healthcare professionals alike.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or above who are admitted to the stroke rehabilitation unit with a clinical diagnosis of stroke.
  • Multi-disciplinary staff working on the stroke rehabilitation unit.

Exclusion criteria

  • Patients with a clinical diagnosis other than stroke.

Treatment and study plan

Primary outcomes

  1. Acceptability and Feasibility of new screening tool among multi-disciplinary staff

    Time frame: From recruitment, throughout 4-6 months of screen implementation, to the completion of focus groups approximately 8 months after recruitment.

    Focus groups will be conducted with staff who administer the new screening tool on the target stroke rehabilitation ward, to explore their views of and experiences with the tool. This will be in relation to the tool's content, structure, length, response/scoring formats, and administration demands.

Secondary outcomes

  1. Uptake and Validity of new screening tool, with patients

    Time frame: Over 4-6 months, from recruitment until the completion of screen implementation.

    Demographic data and stroke-related data (stroke location, severity) will provide descriptive insight into the usability of the tool across subgroups of the sample. Numbers of completed forms will provide descriptive insight into the uptake of the screening tool. Inter-rater reliability will provide insight into the tool's equivalence.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexis Clarke, DClinPsy, QiCN

CONTACT

[email protected]

Georgia M Williams, In Completion of DClinPsy

CONTACT

[email protected]

+447907685213

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Royal Devon and Exeter NHS Foundation Trust

Registry information

Official study title

Development and Exploration of the Acceptability and Feasibility of a Novel Screening Tool for Anosognosia After Stroke, Designed for Routine Use in Hospital Settings.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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